Green Valley Drugs Recalls Medroxyprogesterone Acetate Injection for Sterility Concerns
Green Valley Drugs is recalling Medroxyprogesterone Acetate Injection due to a lack of assurance of sterility in its compounding and quality control processes.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in injectable drugs.
Plain-English summary
FVS Holdings, Inc. dba. Green Valley Drugs is recalling Medroxyprogesterone Acetate Injection, all strengths and presentations. The recall involves 1,299 vials and syringes that were distributed nationwide.
The recall was initiated due to a lack of assurance of sterility in all sterile products compounded, repackaged, and distributed by the pharmacy. This decision was made following concerns associated with the facility's quality control processes.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Medroxyprogesterone Acetate Injection, all strengths and all presentations including a) Medroxyprogesterone 150-30 mL, b) Medroxyprogesterone Acetate 150 mg/mL in 1 mL, 10 mL, 30 mL vials, c) Medroxyprogesterone Acetate 150 mg/mL PF syringe, d) Medroxyprogesterone Acetate 150…
- Manufacturer
- FVS Holdings, Inc. dba. Green Valley Drugs
- Category
- Drug — Injectable
- Affected units
- 1,299
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: a) Medroxyprogesterone 150-30 mL: 20130301-H
- Exp 6/1/2013.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 78 recalled by FVS Holdings, Inc. dba. Green Valley Drugs under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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